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美国FDA是如何管控转基因食品的
作者:羊阳译 【阅读原文】

 

我们管控来自转基因植物(GE)的人类和动物食物像我们规范所有的食物一样。现有的FDA安全要求一个明确的法律义务强加于从农场到餐桌链中的每一个人,以给消费者提供安全的食品,无论这些食物的创建过程如何。生产、处理、存储、运输或向消费者出售不安全的食品是非法的。

We regulate human and animal food from genetically engineered (GE) plants like we regulate all food. The existing FDA safety requirements impose a clear legal duty on everyone in the farm to table continuum to market safe foods to consumers, regardless of the process by which such foods are created. It is unlawful to produce, process, store, ship or sell to consumers unsafe foods.

 

FDA的角色是确保农场到餐桌链中的每个人都承担这个义务。我们鼓励新食品和食品配料的生产者向FDA咨询有关一种成分的监管状态。这个惯例延伸到使用基因工程技术生产的食品。

FDA’s role is to ensure that everyone in the farm to table continuum is meeting this obligation. We encourage producers of new foods and food ingredients to consult with FDA when there is a question about an ingredient’s regulatory status. This general practice extends to foods produced using genetic engineering techniques.

 

植物生物技术咨询程序Plant Biotechnology Consultation Program

FDA于20世纪90年代建立了植物生物技术咨询程序,以与基因工程植物开发人员协同工作并帮助他们确保由他们的基因工程植物新品种加工的食品是安全和合法的。在这个程序中,并在它进入市场之前,我们评估来自新基因工程作物的食品的安全性。FDA created the Plant Biotechnology Consultation Program in the 1990’s to cooperatively work with GE plant developers to help them ensure foods made from their new GE plant varieties are safe and lawful. In this program, we evaluate the safety of food from the new GE crop before it enters the market.

 

尽管咨询程序是自愿的,基因工程植物开发人员在将一个新基因工程植物投放市场之前经常参与它。FDA在1994年完成了它的首次植物生物技术咨询。到目前为止,我们已经通过这个程序评估超过150个基因工程植物品种。完成咨询的列表,请参阅我们的生物技术咨询数据库

Although the consultation program is voluntary, GE plant developers routinely participate in it before bringing a new GE plant to market. FDA completed its first plant biotechnology consultation in 1994. Thus far, we have evaluated more than 150 GE plant varieties through this program. For a list of completed consultations, see our Biotechnology Consultations database.

 

程序是如何工作的How the Program Works

在最初的咨询阶段,基因工程植物开发人员会见FDA并解释他们的基因工程产品。FDA然后提供在安全评估中可能比较重要的有关数据种类和信息的反馈。

During the initial consultation phase, GE plant developers meet with FDA and explain their GE product to FDA. FDA can then provide feedback about the kinds of data and information that would be important to consider in a safety assessment.

 

一旦基因工程植物开发人员完成了安全评估并向FDA提交了评估总结,最后的咨询阶段随即开始。
The final consultation phase begins once a GE plant developer completes its safety assessment and submits a summary of the assessment to FDA.

 

FDA评估总结中的数据和信息,以识别任何未解决的食品安全问题和营养问题或其他法律方面的考虑。我们在这个评估中问的一些问题的例子包括:

FDA evaluates the data and information in the summary to identify any unresolved food safety and nutritional issues or other legal considerations. Some examples of questions we ask in this evaluation include:

  • 来自基因工程植物的食品包含新的毒素或过敏原吗?Does food from the GE plant contain a new toxin or allergen?
  • 来自基因工程植物的食品和传统繁殖的对应食品一样有营养吗?Is food from the GE plant as nutritious as that from its traditionally bred counterpart?

 

如果FDA识别到一个需要解决的问题,我们会与开发人员一起工作以获取解决问题所需的信息。

If FDA identifies an issue that needs to be addressed, we work with the developers to get the information needed to resolve it.

 

当所有的安全及其他监管问题得到解决,并且数据和信息逻辑上支持这样的结论:来自新植物品种的食品将和来自传统繁殖的品种的食品一样安全,我们总结咨询并给基因工程开发人员提供一份回复函。该回复函提醒开发人员,他们仍然有法律义务,以确保他们给市场提供的食品的安全性。

When all safety and other regulatory issues are resolved, and the data and information logically support the conclusion that food from the new plant variety will be as safe as food from conventionally bred varieties, we conclude the consultation with a letter to the GE plant developer. The letter reminds the developer that they remain legally obligated to ensure the safety of the food products they bring to market.

 

最后,FDA在其网站的有关基因工程植物品种的生物技术咨询部分公示的相关信息和文档以供公众查阅。公示内容包括下列事项:

Finally, FDA posts the relevant information and documentation to the Biotechnology Consultations on Food from GE Plant Varieties section of its website for public viewing. The posting includes the following items:

  • 提交日期 Submission date
  • 开发人员的名字和联系信息Developer name and contact information
  • 基因工程植物品种的基本信息Basic information about the GE plant variety
  • FDA的回复函The FDA response letter
  • 一份FDA评估的总结数据和信息的备忘录A memo summarizing the data and information FDA evaluated

 

这只是一个简短的咨询过程的总结。详细的指导,基因工程植物开发人员应该阅读我们的《指导咨询程序——来源于新植物品种的食物》。

This is only a brief summary of the consultation process. For detailed guidance, GE plant developers should read our Guidance on Consultation Procedures – Foods Derived from New Plant Varieties.

 

程序的益处Benefits of the Program

  • FDA通过确保来自基因工程植物的食品的安全和合法性,促进安全的食品供应。Helps FDA promote a safe food supply by ensuring that foods from GE plants are safe and lawful. ·
  • FDA收集来自食品生产商的有关新食品的有价值的数据和信息。Allows FDA to collect valuable data and information about new foods from food producers. 

 

最近更新:2015.10.13

 

相关阅读:FDA对来自基因工程的食品的管理程序EN

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